Clearance Summary
MALLET, BONE SURGERY, STAINLESS STEEL, 2LB. received FDA 510(k) clearance under submission number K871195, sponsored by Military Engineering, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1987-04-06.
- Submission: K871195
- Applicant / Sponsor: Military Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1987-04-06
Classification & Regulation
This clearance is catalogued under FDA product code HXL and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.